Packaging for Stability Testing of Active Substances

Ideally any drug substance entered into a stability programme should be stored in the actual holding containers. However, those which properly represent the actual holding containers used during manufacture may also be used in the stability programme. Containers of reduced size may be acceptable for drug substance stability testing provided that they are constructed of the same material and use the same type of container closure system that is intended to be used during manufacture. The container closure system to be used in the packaging of an active substance must be justified for its intended use.

By Kirsten Nielsen MSc, Head of the Pharmaceutical Packaging Development Department at LEO Pharma A/S
Kirsten Nielsen holds a position as Head of Department, Pharmaceutical Packaging Development at LEO Pharma A/S. She has been with the company for nine years. Prior to that she was with the Danish Packaging and Transportation Research Institute (ATV) after four years with Unilever. Throughout her career she has worked in packaging covering many aspects including production, quality control, research, development, testing, training and technology transfer.

Kirsten has also worked with the European Commission within her area of expertise. During her years at The Danish Packaging and Transportation Research Institute (ATV), Kirsten published her work at international conferences in Austria, Switzerland, Denmark, France, Norway and the US.

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.More info >>